NCT01177917

Brief Summary

This clinical trial will help determine if prebiotics can increase mineral absorption in babies

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2010

Completed
Last Updated

August 9, 2010

Status Verified

August 1, 2010

Enrollment Period

2.1 years

First QC Date

August 6, 2010

Last Update Submit

August 6, 2010

Conditions

Mineral Absorption in the Urine

Outcome Measures

Primary Outcomes (1)

  • To evaluate the amount of minerals in the urine

Secondary Outcomes (1)

  • Compare the amount of vitamins and minerals in the blood

Study Arms (2)

Cow milk-based infant formula with prebiotic blend

EXPERIMENTAL
Other: Infant Formula

Marketed Cow milk-based infant formula

PLACEBO COMPARATOR
Other: Infant Formula

Interventions

Infant FormulaOTHER
Cow milk-based infant formula with prebiotic blendMarketed Cow milk-based infant formula

Eligibility Criteria

Age56 Days - 70 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Singleton
  • Term infant
  • Birth weight of 2500 g or more
  • days of age
  • Signed informed consent
  • Consuming a cow's milk-based infant formula for at least 24 hours.

You may not qualify if:

  • History of underlying disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development or the evaluation of the mineral absorption of the participant
  • Use of multiple vitamin and mineral supplements prior to enrollment.
  • Evidence of formula intolerance or poor intake at time of randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Children's Hospital of Iowa

Coralville, Iowa, 52241, United States

Location

Pediatric Clinical Trials Unit

Louisville, Kentucky, 40202, United States

Location

The Center for Human Nutrition

Omaha, Nebraska, 68105, United States

Location

Cincinnati Children's Hospital Medical Center Clinical Trials Office

Cincinnati, Ohio, 45229, United States

Location

Children's Research and Nutrition Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 6, 2010

First Posted

August 9, 2010

Study Start

August 1, 2006

Primary Completion

September 1, 2008

Study Completion

October 1, 2008

Last Updated

August 9, 2010

Record last verified: 2010-08

Locations

US(5)